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Safety information

20

80028008_030_B – 773625 – 2021-04-29

Guidance and manufacturer's declaration - Range and frequency level: RF wireless communication 
equipment

3.3

Useful life of the system

Provided that all applicable safety and maintenance regulations 
are strictly observed, the video integration system has been 
designed to guarantee a duration of 8 years.

The life cycle includes guaranteeing the functionality of the 
product in compliance with the specific instructions for use, the 
supply of the assistance service and the availability of spare parts;

VIDEOMED applies a certified quality management system 
according to EN ISO 13485 to all its business processes which is a 
guarantee of:

–

highest  quality;

–

product and accessory reliability;

–

ease of use;

–

functional design;

–

optimization for the intended purpose.

Test frequency 

(MHz)

Modulation

Minimum IMMUNITY 

level (V / m)

Applied IMMUNITY 

level (V / m)

385

** Pulse modulation: 18 Hz

27

27

450

 * FM + 5 Hz deviation: 1 kHz sine

 ** Pulse modulation: 18 Hz

28

28

710

745

780

** Pulse modulation: 217 Hz

9

9

810

870

930

** Pulse modulation: 18 Hz

28

28

1720

1845

1970

** Pulse modulation: 217 Hz

28

28

2450

** Pulse modulation: 217 Hz

28

28

5240

5500

5785

** Pulse modulation: 217 Hz

9

9

Содержание Truelink 4

Страница 1: ...Instructions for use Truelink 4 Video Management System ENGLISH en US Read the instructions for use carefully before using the product and keep them safe for future reference...

Страница 2: ...This page is intentionally blank...

Страница 3: ...ion is used This document applies to the following sales units Telephone 39 049 9819113 Fax 39 0434 030689 Document number 80028008 Language ID 030 Version B Material number 773625 Date of publication...

Страница 4: ...ronic PDF format on digital media A paper copy of the manual is available upon request for qualified technical and medical personnel VIDEOMED S r l declines any liability for improper use of the syste...

Страница 5: ...t by the user GENERAL CONSIDERATIONS All operating instructions and recommendations described in this manual must be complied with Clinical personnel must be trained on all operating procedures and sa...

Страница 6: ...Truelink 4 6 80028008_030_B 773625 2021 04 29 This page is intentionally blank...

Страница 7: ...devices 23 4 4 Obligations and prohibitions 23 4 4 1 Personnel prohibitions 24 4 5 Technical data 25 4 6 Measurement and weight layout 30 4 7 System components 35 4 7 1 Main unit 35 4 7 2 Conference u...

Страница 8: ...lecting a patient present in the list 66 6 6 1 2 Entering a new patient 67 6 6 1 3 Entering an emergency patient 68 6 6 1 4 Searching for a patient present in a list 69 6 6 1 5 Patient master data mod...

Страница 9: ...stem units are fitted with identification plates Each plate contains the identification details of the unit to be quoted in case of need to VIDEOMED S r l The plates present are shown below Unit Image...

Страница 10: ...ation 10 80028008_030_B 773625 2021 04 29 Truelink 4 Main Unit AR Truelink 4 Main Unit ARD Truelink 4 Main Unit ARSD Truelink 4 Main Unit ARS Truelink 4 Main Unit SSD R Truelink 4 Conference Truelink...

Страница 11: ...e identification plates and or replace them with other plates If the plates are damaged or removed the customer must notify the Manufacturer Truelink 4 UHD Plus Truelink 4 TCM Separable component Main...

Страница 12: ...Processes ANSI AAMI IEC 62366 1 2015 Medical devices Part 1 Application of usability engineering to medical devices AAMI ANSI HE75 2009 Human Factors Engineering Design Of Medical Devices AAMI ANSI E...

Страница 13: ...iption Regulation EU 2017 745 Regulation on medical devices amending Directive 93 42 EEC will enter into force on 26 May 2021 93 42 EEC Medical Devices Directive MDD and f m 2007 47 EC EN 1041 2008 In...

Страница 14: ...t or resale It is the user s responsibility to keep this documentation intact so that it may be consulted throughout the entire lifespan of the system 2 2 Updates VIDEOMED S r l reserves the right to...

Страница 15: ...e operation of the system and ensures that it is used solely for the intended purpose Qualified Personnel Authorized persons who are generally employees of the manager or who have acquired their skill...

Страница 16: ...the VIDEOMED material number Symbol used to indicate the serial number Symbol used to indicate a medical device Indicates the Unique Device Identification UDI code is composed of UDI DI 01 and UDI PI...

Страница 17: ...Lead and Di 2 ethylhexyl phthalate DEHP which are known to the State of California to cause cancer and Lead and Di 2 ethylhexyl phthalate DEHP which are known to the State of California to cause birth...

Страница 18: ...tivities on the electrical equipment carried out in a non compliant manner or incorrect replacement of components may compromise the efficiency of the solutions adopted The Truelink 4 product is a Cla...

Страница 19: ...level The quality of the mains supply must be that typical of a commercial and or hospital environment Pulses IEC 61000 4 5 0 5 1 kV differential mode 0 5 1 2 kV in common mode IEC 60601 1 2 Test leve...

Страница 20: ...he assistance service and the availability of spare parts VIDEOMED applies a certified quality management system according to EN ISO 13485 to all its business processes which is a guarantee of highest...

Страница 21: ...tion Inform the operator of any defects 3 4 1 Preparing the system Pull the plug of the power cord out of the socket For permanent installations turn off the main switch place on the front panel of th...

Страница 22: ...with the defined maintenance intervals by qualified service technicians Initial operation by the operator Repair and disposal of the MD must be performed by qualified service technicians as required...

Страница 23: ...Use associated with other medical devices The Truelink 4 Video Management System can be used with medical devices from other manufacturers The operation of these devices is described in the relevant o...

Страница 24: ...y system components without the permission of the Manufacturer use the system as a support point even if not operational resulting in the risk of falling and or damaging the system itself use the syst...

Страница 25: ...age Input Output 4000 V AC Input FG 1500 V AC Enclosure IP20 Environmental conditions Operating temperature 10 40 C Operating relative humidity range 30 to 75 Operating atmospheric pressure range 54 0...

Страница 26: ...W Protection Short circuit protection Overload protection Overcurrent protection Overvoltage protection Insulation Voltage Input Output 4000 V AC Input FG 1500 V AC Environmental conditions Operating...

Страница 27: ...ply 100 240 V 50 60Hz AC Power Consumption 30 W Protection Short circuit protection Overload protection Overcurrent protection Overvoltage protection Insulation Voltage Input Output 4000 V AC Input FG...

Страница 28: ...450 mm Power Supply 100 240 V 50 60Hz AC Power Consumption 30 W Protection Short circuit protection Overload protection Overcurrent protection Overvoltage protection Insulation Voltage Input Output 40...

Страница 29: ...perating atmospheric pressure range 70 0 kPa to 106 0 kPa Storage temperature 40 70 C Storage relative humidity range 10 to 100 including condensation Storage atmospheric pressure range 50 0 kPa to 10...

Страница 30: ...System description 30 80028008_030_B 773625 2021 04 29 4 6 Measurement and weight layout MAIN UNIT Dimensions 133 x 430 x 450 mm Unit Weight 13 5 kg Rack Dimensions optional Rack Brackets optional...

Страница 31: ...System description 80028008_030_B 773625 2021 04 29 31 CONFERENCE UNIT Dimensions 44 x 430 x 450 mm Unit Weight 8 kg Rack Brackets optional Rack Dimensions optional...

Страница 32: ...System description 32 80028008_030_B 773625 2021 04 29 UHD UNIT Dimensions 44 x 430 x 450 mm Unit Weight 5 5 kg Rack Brackets optional Rack Dimensions optional...

Страница 33: ...System description 80028008_030_B 773625 2021 04 29 33 UHD PLUS UNIT Dimensions 44 x 430 x 450 mm Unit Weight 5 5 kg Rack Brackets optional Rack Dimensions optional...

Страница 34: ...System description 34 80028008_030_B 773625 2021 04 29 RACK UNIT Dimensions 800 x 600 x 757 mm Unit Weight 64 kg ADJUSTABLE FOOT HEIGHT...

Страница 35: ...tion ports are located on the back of the unit They are divided into the following sections The connection cables are supplied VIDEOMED S r l 1 MAIN UNIT 2 CONFERENCE UNIT 3 UHD UNIT or UHD PLUS UNIT...

Страница 36: ...ED S r l 4 7 3 UHD unit The new identification plates are still missing The UHD unit allows full management of signals with 4K Ultra HD resolution The following connection ports are located on the bac...

Страница 37: ...surgical lights with surgical video camera Trumpf Medical operating table The complete functions present in the Control Software are described in detail in the User Interface chapter of these instruct...

Страница 38: ...The delivery of the Truelink 4 Video Management System is validated by a document signed by the operator Once the system has been commissioned the instructions contained in this manual are binding fo...

Страница 39: ...ent DVI 3G HD SD SDI CVBS Composite VGA The technical drawing shows an example of the connection plates installed on the pendant panels 5 5 System shutdown To shut down the system proceed as follows I...

Страница 40: ...n off button installed inside the operating room typically on a pendant panel or wall unit Thanks to this solution the operator can manage the entire video management system without having to access t...

Страница 41: ...video conference the streaming and the advanced modes Privacy Mode Do Not Disturb and Lecture Mode are also present 2 MAIN SECTION Area for the functions to select the source and identify the monitor...

Страница 42: ...monitor settings can be accessed brightness intensity of the entire display screen contrast the difference in brightness between the different light and dark areas of the screen The menu control sett...

Страница 43: ...signals can be routed to any monitor in the operating room The main Video Routing screen is divided as follows To send a video signal to a monitor drag the relevant image from the Source List A availa...

Страница 44: ...ge or reduce the preview of the video signal of each connected source If the preview is enlarged it will only appear momentarily on the screen To display the Live Preview of one of the signals availab...

Страница 45: ...yed signal If the icon is gray it indicates that the function is not active To activate the function it is required to select a patient from the list refer to paragraph Selecting a patient present in...

Страница 46: ...possible to use an additional quick activation system from the Video Routing function To perform the recording from the Video Routing function proceed as follows In systems where the dual recording ch...

Страница 47: ...one of the connected sources When streaming is active the button is in white background in the box of the selected source and is disabled in the Previews of the remaining sources Pressing in a Previe...

Страница 48: ...t the zoom of the Roomcam proceed as follows 6 3 4 2 Roomcam movement adjustment To adjust the movement of the Roomcam proceed as follows Step Image 1 Use and to adjust the zoom to obtain the desired...

Страница 49: ...g Preset To save a specific video camera setting Preset proceed as follows Step Image 1 After adjusting the video camera to the desired position press 2 Enter the name to be assigned and press to conf...

Страница 50: ...50 80028008_030_B 773625 2021 04 29 6 3 4 4 Delete camera setting Preset To delete a video camera setting from the Preset list proceed as follows Step Image 1 Press 2 Press and hold the button until...

Страница 51: ...herefore possible to save and then modify images and videos stored on a 1TB on board support expandable up to 2TB as an option It is then possible to send the recorded material to a dedicated server c...

Страница 52: ...surgical activity images and video at any time by pressing the icon This way a list will appear on the screen containing all previews of stored files which can then be reproduced and processed by usin...

Страница 53: ...et a Live Preview of the signal and the basic and advanced recording functions will be enabled The following icons are present in the Recording Channel window Channel selection and recording will in n...

Страница 54: ...edicated to them Through the green number in the icon it will be possible to see how many media have been associated with that patient Click on the icon to access the storage folder Step Image 1 Press...

Страница 55: ...ideos related to the selected patient 2 Press the icon to enlarge the single media 3 A new window appears which depending on the file selected image or video allows you to Icon Function Delete the fil...

Страница 56: ...os proceed as follows Step Image 1 Press to view all images and videos related to the selected patient 2 Press the icon to enlarge the single element 3 Press the icon A cursor appears on the progress...

Страница 57: ...nterface 80028008_030_B 773625 2021 04 29 57 4 Once the cutting points are determined extract the portion of the video by pressing A new video appears in the photo video list of the same patient Step...

Страница 58: ...the captured images and videos is displayed The following icons are present in the Export window The standard system configuration involves exporting to a device connected to the USB port To export pr...

Страница 59: ...g USB device not present the system displays an EXPORT FAILED error message and the icon appears on the right side of the screen The files that the system failed to export are indicated with a red se...

Страница 60: ...eos of the selected patient To delete images and videos proceed as follows Step Image 1 Select the videos or images you wish to delete by clicking directly on their thumbnail The outline of the select...

Страница 61: ...transmission channels Images or video sources All connected sources are displayed in the input signal bar Swap Button During a conference it is possible to change the signals displayed in the layout s...

Страница 62: ...the video conference is active the dashboard receiver icon turns green 6 5 1 Select the signals to be sent by video conference From the Source List drag the source you wish to send in video conference...

Страница 63: ...eo conference Press one of the boxes related to the primary and or secondary video conference channel and then to the icon which will be shown inside it to remove the video signal from the video confe...

Страница 64: ...ative icon depending on the mode on the right side of the screen The icons are described below Icon Description Image Enables to select a name from the contact list Enables to select a name address fr...

Страница 65: ...ws access to the Check List screens relating to the surgery Allows access to the Preset Workflows screens of the Room configuration Allows access the Multiview setup screens Allows access the Audio se...

Страница 66: ...he screen displayed when the icon is pressed the list of patients A already entered and divided between those imported by the Worklist if present and those previously manually selected or inserted is...

Страница 67: ...patient To enter a new patient proceed as follows 2 Press to confirm the selection Step Image Step Image 1 Select the icon on the right of the screen The window for filling in patient data is display...

Страница 68: ...ionalities available and management the Emergency Patient is comparable to any patient manually entered or by recalling the Worklist To enter an emergency patient proceed as follows 3 Once the mandato...

Страница 69: ...follows 6 6 1 5 Patient master data modification To modify a patient s master data proceed as follows Step Image 1 Enter the surname or ID in the specific field in the right section Step Image 1 Searc...

Страница 70: ...stem is configured to dialogue with the centralized master data management system the patient list relative to the date room surgeon can be called up by using the button To access the worklist proceed...

Страница 71: ...lth Organization as default concerning each stage of the surgical procedure Press the icon to scroll through the questions The instructions refer to the entire procedure it will therefore be possible...

Страница 72: ...eset On the side menu press the icon to access the Preset screens The Preset enable to save room settings configurations It will then be possible to recall the configurations by pressing the relative...

Страница 73: ...g Video Recording Channel Conference Channel Setting Audio Operating Light Setting 2 Press the button The configuration window opens 3 Enter the name to be assigned to the new Preset and add a descrip...

Страница 74: ...as follows Press the icon to automatically activate the Preset each time the system is started 5 Press to confirm Step Image Step Image 1 Select the desired Preset from the Preset List The configurat...

Страница 75: ...6 4 Multiview On the side menu press the icon to access the Multiview screen The Multiview function enables to combine multiple Inputs up to a maximum of 4 into a single Output signal The main screen...

Страница 76: ...e and Picture Quadview Picture Over Picture Picture In Picture 2 Drag the images one at a time from the Source List and drop them into the corresponding boxes Press which will appear at the top right...

Страница 77: ...On the side menu press the icon to access the Audio Control screen In the Audio Control section it is possible to set the volume levels of the inputs microphones and outputs speakers in the room The m...

Страница 78: ...he event that the system receives a connection request in video conference the system will automatically silence lines AUX1 AUX2 and activate the video conference line This option is set by default if...

Страница 79: ...0028008_030_B 773625 2021 04 29 79 6 6 5 2 Disabling microphones and audio To disable the microphones or line inputs proceed as follows Step Image 1 Press to disable the microphone 2 Press to turn off...

Страница 80: ...pectively to the 2 operating lights installed in the operating room The image shows the case where the lamp control system cannot be reached Truelink 4 Video Management System assures the option of co...

Страница 81: ...n can also be activated Light beam size Shadow setting the automatic function can also be activated the function may vary based on the light model installed 6 6 7 Environmental control panel managemen...

Страница 82: ...nction Truelink 4 Video Management System includes a Lock function to lock the touchscreen by using a PIN To lock the touchscreen proceed as follows Step Image 1 Press to lock the screen 2 Enter the P...

Страница 83: ...be set as active by default at system startup or only after a Logout The Login screen requires 2 mandatory fields to fill in Username and Password in order to access the system Once the correct crede...

Страница 84: ...new products VIDEOMED S r l offers a waste collection and environmentally sustainable disposal service for all products VIDEOMED S r l Recycling and disposal is performed by VIDEOMED S r l at no addi...

Страница 85: ...Source List Select the desired layout from PiP PaP PoP and Quadview Then proceed to populate this layout by dragging one at a time the images of the sources and releasing them in the relative boxes T...

Страница 86: ...wnload the patient list in automatic mode Urgent insertion With this option it is possible to create a study with a random ID name called Emergency Patient 8 6 Selection of signals to be recorded Drag...

Страница 87: ...This page is intentionally blank...

Страница 88: ...80028008_030_B 773625 2021 04 29...

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